Everting transcatheter valve and methods

Abstract

Described embodiments are directed toward centrally-opening, leaflet valve devices and systems for transcatheter delivery having a two-piece valve body as well as methods of making and delivering the two-piece valve devices. A transcatheter valve includes a collapsed configuration and an expanded configuration. The transcatheter valve can further include an everted configuration and a non-everted configuration.

What is claimed: 
     
       1. A method of delivering, via an intravascular procedure, a transcatheter valve including a multi-part frame having a first portion and a second portion, and one or more leaflets coupled to the multi-part frame, the transcatheter valve having a collapsed configuration and an expanded configuration, the method comprising:
 positioning the transcatheter valve at an implantation site in the collapsed configuration; 
 expanding the transcatheter valve; 
 everting the multi-part frame of the transcatheter valve; and 
 securing the transcatheter valve at the implantation site; further comprising loading the transcatheter valve onto a distal section of an elongated flexible catheter such that the first portion of the multi-part frame is coaxially, laterally adjacent to an spaced apart from the second portion of the multi-part frame and transcatheter valve is in the collapsed configuration. 
 
     
     
       2. The method of  claim 1 , wherein positioning the transcatheter valve at the implantation site includes delivering the transcatheter valve to a native valve orifice intravascularly. 
     
     
       3. The method of  claim 1 , wherein expanding the transcatheter valve includes expanding the transcatheter valve into a native valve orifice. 
     
     
       4. The method of  claim 1 , wherein transitioning the transcatheter valve to an everted configuration includes everting the second portion of the multi-part frame into the first portion of the multi-part frame. 
     
     
       5. The method of  claim 1 , wherein the first portion of the multi-part frame defines a generally tubular shape and the second portion of the multi-part frame defines a generally annular shape, the first and second portions of the multi-part frame being coupled by a film bridge defining a fold region between the first and seconds portion of the multi-part frame. 
     
     
       6. The method of  claim 1 , wherein the first and second portions of the multi-part frame have different stiffnesses. 
     
     
       7. The method of  claim 1 , wherein at least one of the first and second portions of the multi-part frame is formed of non-shape memory material. 
     
     
       8. The method of  claim 1 , wherein the first portion of the multi-part frame is formed of an open framework operable to be compressed to a collapsed configuration and expanded to an expanded configuration. 
     
     
       9. The method of  claim 1 , wherein following securement of the transcatheter valve at the implantation site, the second portion of the multi-part frame is held adjacent to the first portion of the multi-part frame by a spring bias of the second portion of the multi-part frame.